HealthyNCT00153335
Computerized Risk Assessment in an Employee Population
A study testing patient-provider interaction in people with Healthy, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This is a study to determine whether a computerized risk assessment and focused patient provider interaction can improve health outcomes in an employee population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- patient-provider interaction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees who use University of New Mexico providers for medical care
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
About this study
This is a study to determine whether a computerized risk assessment and focused patient provider interaction can improve health outcomes in an employee population.
Read the detailed description
The overall goal of the proposed research is to test the effectiveness of a theoretically-based interactive behavioral and health risk assessment system to improve the mental and physical health outcomes of the primary care provided for the adult multicultural members of a university health center-employee-based practice. The new system will include:
- administration of a computerized behavioral and health risk assessment,
- calculation of an individualized risk profile for each patient participant,
- individual patient computerized video training in interaction focused on the risk profile,
- physician training in patient-provider interaction, motivational interviewing and counseling, and in referral and triage focused on the risk profile, and
- development of a negotiated care plan between patient and clinician for follow-up care.
Expected outcomes include changes in: risk category scores, utilization patterns, costs for health care services, and health stage of change indicators. Expected impacts (mediating variables) are: compliance with recommendations, health locus of control, differences in patient-provider interaction patterns and patient and clinician satisfaction. If successful, this methodology would contribute significantly to the health promotion goals of Healthy People 2010 and provide much needed evidence of how a behavioral and health risk assessment system can help to reduce ethnic health disparities of multi-cultural populations. This proposal is responsive to CDC's RFA for Health Promotion in the Workplace; in particular it responds to requests for strategy #6: Identification and evaluation of public health informatics and communication strategies and tools to improve health decisions, health alerting, health literacy, or health assessment among employees and employer.
- Conditions
- Healthy
- Being tested
- patient-provider interaction
- Keywords
- Health Risk Assessment, Behavior Change, Patient-Provider Interaction, Employee Health, Absenteeism, Tobacco Use, Substance Use, Diet, Exercise, Medication Adherence
- Medical subject headings
- Tobacco Use, Substance-Related Disorders, Motor Activity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-provider interactionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction at time of visit
Utilization of health services at one year
Health outcome at one year
Secondary outcomes (3)
Stage of change for health behaviors at one year
Quality of life at one year
Work performance at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of New Mexico
- Investigators
- Deborah L. Helitzer, ScD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153335
- Sponsor's protocol ID
- CDC-OPHR-R01CD000122
- Other IDs
- R01CD000122
- Status last verified
- Feb 2010
- First submitted
- 7 Sep 2005
- Last updated
- 26 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Risk Assessment in an Employee Population
- ClinicalTrials.gov ID
- NCT00153335
- Acronym / sponsor ID
- CDC-OPHR-R01CD000122
- Conditions
- Healthy
- Keywords
- Health Risk Assessment, Behavior Change, Patient-Provider Interaction, Employee Health, Absenteeism, Tobacco Use, Substance Use, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of New Mexico
- Study start
- Jun 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine whether a computerized risk assessment and focused patient provider interaction can improve health outcomes in an employee population.
Detailed description
The overall goal of the proposed research is to test the effectiveness of a theoretically-based interactive behavioral and health risk assessment system to improve the mental and physical health outcomes of the primary care provided for the adult multicultural members of a university health center-employee-based practice. The new system will include:
- administration of a computerized behavioral and health risk assessment,
- calculation of an individualized risk profile for each patient participant,
- individual patient computerized video training in interaction focused on the risk profile,
- physician training in patient-provider interaction, motivational interviewing and counseling, and in referral and triage focused on the risk profile, and
- development of a negotiated care plan between patient and clinician for follow-up care.
Expected outcomes include changes in: risk category scores, utilization patterns, costs for health care services, and health stage of change indicators. Expected impacts (mediating variables) are: compliance with recommendations, health locus of control, differences in patient-provider interaction patterns and patient and clinician satisfaction. If successful, this methodology would contribute significantly to the health promotion goals of Healthy People 2010 and provide much needed evidence of how a behavioral and health risk assessment system can help to reduce ethnic health disparities of multi-cultural populations. This proposal is responsive to CDC's RFA for Health Promotion in the Workplace; in particular it responds to requests for strategy #6: Identification and evaluation of public health informatics and communication strategies and tools to improve health decisions, health alerting, health literacy, or health assessment among employees and employer.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employees who use University of New Mexico providers for medical care
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-provider interaction | Behavioural | – |
Primary outcome
Satisfaction at time of visit
Utilization of health services at one year
Health outcome at one year
3 secondary outcomes
Stage of change for health behaviors at one year
Quality of life at one year
Work performance at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah L. Helitzer, ScD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient-provider interaction in people with Healthy, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction at time of visit. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.